Answer given by Ms Vassiliou on behalf of the Commission
15.7.2008
Benzoic acid (E 210) and sodium (E 211), potassium (E 212) and calcium (E 213) benzoates are permitted preservatives within the European Union under Parliament and Council Directive 95/2/EC[1] (as amended). This directive sets out the food categories and maximum levels permitted. Benzoates are permitted only in certain foods and maximum levels vary from 150 to 500 milligram per kilogram (mg/kg) or milligram per litre (mg/l), and only in some products are maximum levels of up to 2 000 mg/kg permitted to be used.
Benzoates were most recently evaluated by the Scientific Committee on Food in 2002 at which time they established a full acceptable daily intake (ADI) of 5 mg/kg bodyweight per day.
According to EU legislation, official controls including those to verify whether food additives are used in compliance with the provisions set in the Community law are carried out by the Member States. EU legislation also requires that Member States have systems in place to monitor the consumption and use of food additives and report to the Commission. On the basis of such data, the Commission published in 2001 a report on dietary food additive intake in the EU[2]. The report included the calculated intake estimates of benzoates based on actual food consumption data combined with maximum use levels and assuming that the additives implicated are used in the widest possible range of foods; as a consequence of that assumption, the methodology followed can be considered as conservative in approach. Thus, the intake estimated is reported for adults in the range of 6-84 % of the ADI and for young children in the range of 17- 96 % of the ADI. The Commission with the assistance of the Member State experts, the European Food Safety Authority (EFSA) and EU Industry umbrella associations has initiated a new action for the collection of data in order to update and refine the calculation of the dietary food additive intake in the Community.
In relation to the proposed regulation on food additives which is part of the Commission's package of proposals on food improvement agents, the Commission has asked EFSA to undertake a re-evaluation of all currently permitted food additives, including benzoic acid and its salts.
The Commission is aware of press coverage relating to a 1999 study (hereafter the ‘Southampton study’) undertaken by Professor Peter Piper which examined the effect of benzoic acid on yeasts. In its conclusions the study raised the question of whether this effect could be relevant to human exposure to this additive. The Commission is not however aware of any further studies which have been undertaken in this area. The Commission has asked EFSA to consider whether in light of this study, the re-evaluation of benzoic acid and its salts needs to be prioritised. With regard to the study investigating the effect of certain additives on children's behaviour, EFSA has assessed the results of the study and concluded on 7 March 2008 that the findings cannot be used as a basis for altering the ADI of sodium benzoate.
Nevertheless, in the framework of the proposal for a regulation on food additives, and amendment has been adopted which foresees the warning labelling of products containing any of the colours assessed in the Southampton study in relation to hyperactivity in children.
In relation to whether other producers have undertaken a substitution of sodium benzoate, it should be noted that in 2006 evidence came to light that under certain conditions, low levels of benzene may be formed in soft drinks as a result of the reaction of benzoic acid and other ingredients. In response to this, the soft drink industry promptly prepared guidance for manufacturers on methods for reducing the potential formation of benzene and, where possible, reformulated their products in order to minimise benzene formation. Since then Member States have undertaken surveillance, and monitoring results have shown that the reformulation was generally successful.
Finally, it should be noted that all food additives are under continuous observation and are evaluated whenever necessary in the light of new scientific information. If, as a consequence, EFSA would advise at any point that the additive is not safe for consumers, the Commission would take appropriate action.
- [1] Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners, OJ L 61, 18.3.1995.
- [2] COM(2001)542 final.